Efficacy of Neurofeedback Training in Adults With ADHD
8. mars 2017 oppdatert av: Dr. Michael Schoenenberg, University Hospital Tuebingen
Efficacy of a Neurofeedback Treatment in Adults With ADHD: a Triple-blind Randomized Placebo-controlled Study
Neurofeedback training (NFT) has been frequently investigated as an alternative treatment for ADHD mainly in children and adolescents. However, randomized double-blind trials that include a sham-neurofeedback control group are lacking, as well as studies examining the efficacy of NFT in adult ADHD populations. The inclusion of a sham-neurofeedback group is crucial to monitor and exclude unspecific effects.
This study aims to investigate the efficacy of NFT as compared to a sham-feedback condition and a cognitive behavioral treatment in adults with persistent ADHD.
Efficacy is assessed on several outcome parameters, such as symptom severity, neuropsychological variables (e.g., attention, memory), and EEG parameters.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
118
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Baden-Württemberg
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Tuebingen, Baden-Württemberg, Tyskland, 72076
- Universitat Tubingen
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 60 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion criteria:
- ADHD diagnosis
- sufficient knowledge of the German language
Exclusion criteria:
- psychiatric disorder(s) lifetime (bipolar disorder, schizophrenia, schizoaffective disorder, borderline personality disorder)
- neurological disorder (e.g., epilepsy)
- current substance abuse disorder
- receives psychotherapy (e.g., CBT) or medication
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Neurofeedback active
Active neurofeedback training, theta/beta-protocol
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Sham-komparator: Neurofeedback sham
Neurofeedback training is simulated to subjects in this condition
|
Andre navn:
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Aktiv komparator: Metacognitive Training
Metacognitive training, cognitive behavioral therapy
|
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in ADHD symptomatology
Tidsramme: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
Conners' Adult ADHD Rating Scale (CAARS) Scores
|
pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in co-morbid depression scores
Tidsramme: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
Beck Depression Inventory (BDI) Scores
|
pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
|
Changes in co-morbid anxiety scores
Tidsramme: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
State Trait Anxiety Inventory (STAI) Scores
|
pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
|
Changes in neuropsychological variables: Attention
Tidsramme: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
Continuous Performance Test (CPT), Errors in Omission and Errors in Commission
|
pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
|
Changes in neuropsychological variables: Interference
Tidsramme: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
Stroop Color-Word Test, Interference scores
|
pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
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Changes in neuropsychological variables: Cognitive Flexibility 1
Tidsramme: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
Test for Attentional Performance (TAP) - Flexibility, RT in ms and Errors
|
pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
|
Changes in neuropsychological variables: Cognitive Flexibility 2
Tidsramme: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
Inventory for Complex Attention (INKA), Items correctly performed
|
pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
|
Changes in electrophysiological markers
Tidsramme: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
Ln-transformed theta/beta ratio
|
pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
|
Changes in event-related potentials 1
Tidsramme: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
Contingent Negative Variation Amplitudes
|
pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
|
Changes in event-related potentials 2
Tidsramme: pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
Emitted P 300 Amplitudes
|
pre-treatment, after 8 weeks (mid-treatment), after 15 weeks (post-treatment) and after 6 months (follow-up)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Michael Schönenberg, Dr, University Hospital Tuebingen
- Studiestol: Martin Hautzinger, Prof. Dr., University Hospital Tuebingen
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. februar 2013
Primær fullføring (Faktiske)
1. desember 2015
Studiet fullført (Faktiske)
1. november 2016
Datoer for studieregistrering
Først innsendt
21. februar 2013
Først innsendt som oppfylte QC-kriteriene
18. juni 2013
Først lagt ut (Anslag)
21. juni 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. mars 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. mars 2017
Sist bekreftet
1. mars 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SCHO 1448/2-1
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
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